Foot SurgeryNCT05354791
Pre-post Spinal Popliteal Block
An observational study of Foot Surgery and Ankle Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Foot Surgery, Ankle Surgery
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigators plan to analyze data for patients who underwent ambulatory foot or ankle procedures with the use of spinal anesthesia and sciatic nerve block in the popliteal fossa at HSS between March 1, 2016 and February 24, 2020
Who may be able to join
- ambulatory foot surgery
- ambulatory ankle surgery
- use of spinal Anesthesia
- use of pre-spinal anesthesia nerve block techniques
- use of sciatic nerve block
Who cannot join
- all other surgeries
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Comparison of Success and Injury (Neuropraxia) Rate When Performing the Sciatic Nerve Block in the Popliteal Fossa Pre vs. Post Spinal Anesthesia for Foot and Anke Procedures: Retrospective Review
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.
Read the detailed description
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.
Primary outcome:
- The investiigators will be looking into persistent abnormal neuropathic symptoms lasting more than 7 days following a sciatic popliteal nerve block.
- Conditions
- Foot Surgery, Ankle Surgery
- Keywords
- lower extremity peripheral nerve block, spinal anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Abnormal Neuropathic Symptoms
Definition of abnormal neuropathic symptoms including numbness, tingling, burning, or pain sensation.
Measured: lasting more than 7 days following a sciatic popliteal nerve block
Secondary outcomes (5)
NRS pain scores in recovery
A score on a scale from 0 to 10 on how bad the pain is. 0 means no pain, 10 means worst pain. A lower score means a better outcome.
Measured: PACU recovery stay (up to 48 hours)
Amount of supplemental analgesic and antiemetic provided in the PACU
This includes: IV dilaudid push, oral oxycodone, tramadol, hydrocodone, dilaudid, acetaminophen, ketorolac, ondansetron, dexamethasone.
Measured: PACU recovery stay (up to 48 hours)
Anesthesia induction time
time from entering the OR to time of anesthesia induction end as defined by the completion of both the spinal and sciatic nerve blockade
Measured: From the time which patients enter the OR to time of anesthesia induction end (up to 24 hours)
Number of hypoxemia events during induction time
Measured: during induction time (up to 24 hours)
Amount of sedation given
fentanyl, ketamine, midazolam, propofol
Measured: during induction time (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 May 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: Retrospective study that the PI decided not to proceed with
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang Kim, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354791
- Sponsor's protocol ID
- 2019-1642
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Success and Injury (Neuropraxia) Rate When Performing the Sciatic Nerve Block in the Popliteal Fossa Pre vs. Post Spinal Anesthesia for Foot and Anke Procedures: Retrospective Review
- ClinicalTrials.gov ID
- NCT05354791
- Acronym / sponsor ID
- 2019-1642
- Conditions
- Foot Surgery, Ankle Surgery
- Keywords
- lower extremity peripheral nerve block, spinal anesthesia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Retrospective study that the PI decided not to proceed with
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.
Detailed description
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.
Primary outcome:
- The investiigators will be looking into persistent abnormal neuropathic symptoms lasting more than 7 days following a sciatic popliteal nerve block.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators plan to analyze data for patients who underwent ambulatory foot or ankle procedures with the use of spinal anesthesia and sciatic nerve block in the popliteal fossa at HSS between March 1, 2016 and February 24, 2020
Key inclusion criteria (5 listed)
- ambulatory foot surgery
- ambulatory ankle surgery
- use of spinal Anesthesia
- use of pre-spinal anesthesia nerve block techniques
- use of sciatic nerve block
Key exclusion criteria (1 listed)
- all other surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistent Abnormal Neuropathic Symptoms
Time frame: lasting more than 7 days following a sciatic popliteal nerve block
Definition of abnormal neuropathic symptoms including numbness, tingling, burning, or pain sensation.
5 secondary outcomes
NRS pain scores in recovery
Time frame: PACU recovery stay (up to 48 hours)
Amount of supplemental analgesic and antiemetic provided in the PACU
Time frame: PACU recovery stay (up to 48 hours)
Anesthesia induction time
Time frame: From the time which patients enter the OR to time of anesthesia induction end (up to 24 hours)
Number of hypoxemia events during induction time
Time frame: during induction time (up to 24 hours)
Amount of sedation given
Time frame: during induction time (up to 24 hours)
Results and safety
The study was stopped early (reason given: Retrospective study that the PI decided not to proceed with). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Kim, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Surgery and Ankle Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Retrospective study that the PI decided not to proceed with). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Abnormal Neuropathic Symptoms (time frame: lasting more than 7 days following a sciatic popliteal nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.